FDAnews Device Daily Bulletin

Veracyte Launches Envisia Genomic Classifier

Oct. 26, 2016

Veracyte has launched its Envisia genomic classifier for improved diagnosis of idiopathic pulmonary fibrosis.

The Envisia classifier utilizes machine learning coupled with deep RNA sequencing to detect the presence or absence of usual interstitial pneumonia (UIP).

At the CHEST Annual Meeting 2016, a demonstration was presented of clinical evidence that the device was trained on over 350 samples obtained through bronchoscopy from 90 patients participating in the ongoing, prospective 30-site BRAVE study.

The company will begin making the Envisia genomic classifier available to a limited number of institutions in December. — Cynthia Jessup

View today's stories